Study of Canfosfamide in Refractory or Relapsed Mantle Cell, Diffuse Large B Cell Lymphoma and Multiple Myeloma

Phase 2

Completed

• Conditions: Mantle Cell Lymphoma; B Cell Lymphoma; Multiple Myeloma
• Interventions: Drug: Canfosfamide HCl for injection

• Registration Number: NCT01148108
• Lead Sponsor: Telik

Brief Summary

This is a Phase 2 study to determine the efficacy and safety of canfosfamide treatment in relapsed or refractory mantle cell lymphoma, diffuse large B cell lymphoma and multiple myeloma. The study will be conducted in two stages with 5-6 patients in each indication in Stage 1 and if responses are observed an additional 10 patients in Stage 2 in each group.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-17
• Study First Submitted QC: 2010-06-18
• Study First Posted: 2010-06-22
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-13
• Last Update Posted: 2013-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• relapsed or refractory disease
• histologically or cytologically confirmed disease
• characteristic immunophenotypic profiles
• measurable disease (for lymphoma patients)
• ECOG performance status of 0-2
• adequate liver and kidney function
• adequate bone marrow reserves
• ineligible or unwilling to undergo autologous stem cell transplantation

Exclusion Criteria

• failure to recover from any major surgery within 4 weeks of study entry
• pregnant or lactating women
• women of child-bearing potential not using reliable and appropriate contraception
• routine prophylactic use of G-CSF required within 2 weeks of study entry
• Grade 3 or higher peripheral neuropathy
• history of hepatitis B virus or HIV
• central nervous system or meningeal involvement by lymphoma or multiple myeloma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mantle Cell Lymphoma	Canfosfamide HCl for injection	Patients with relapsed or refractory mantle cell lymphoma
Diffuse Large B Cell Lymphoma	Canfosfamide HCl for injection	Patients with relapsed or refractory diffuse large B cell lymphoma
Multiple Myeloma	Canfosfamide HCl for injection	Patients with relapsed or refractory multiple myeloma

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	At 24 weeks of treatment	Disease will be assessed every 6 weeks using International Working Group Response Criteria for Non-Hodgkins Lymphoma in the mantle cell and diffuse large B cell lymphoma patients and the International Myeloma Working Group Response Criteria for multiple myeloma patients. Patients will continue to be treated and disease assessed until disease progression or unacceptable toxicity.

Secondary Outcome Measures

Name	Time	Method
Duration of Response	At 6, 12, 18 & 24 weeks of treatment	Duration of response will be determined after disease progression is documented in patients who have an objective response.
Safety Assessments	At 3, 6, 9, & 12 weeks of treatment	Toxicity will be assessed throughout study using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0.

Trial Locations

Locations (1)

Cancer Institute of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States